The Law of Compounding Medications And Drugs

Wednesday, April 30, 2014

By Drake Bennett April 30, 2014
The horrifyingly botched execution on Tuesday in Oklahoma—in which the condemned man, Clayton D. Lockett, woke during the lethal injection, called out, writhed in pain, and died of a heart attack after officials tried to halt the execution—is sure to be a touchstone in the long-running national argument over capital punishment. It also revealed the surprisingly jerry-built system that states have come to rely on for procuring the drugs used in lethal injections.
That system has increasingly come to resemble the trade in illegal drugs. Prison officials cross state lines with tens of thousands of dollars in cash to buy sedatives and anesthetics from compounding pharmacies whose identities are concealed. Attorneys for death-row inmates in Oklahoma and elsewhere have been trying to force states to reveal the sources of the lethal-injection drugs, arguing that it’s impossible to know whether the compounds will work as intended without knowing where they came from. Federal agents in 2011 seized Georgia’s supply of a barbiturate, sodium thiopental, after defense attorneys raised concerns about its origins.
There’s clearly cause for concern. The drug cocktail used in executions is supposed to paralyze the condemned and render him unconscious before death, but the Oklahoma case isn’t the only one to fall far short of this standard. In January, a condemned man in Ohio gasped and convulsed for 15 minutes while being put to death. Also in January, an Oklahoma convict’s last words after his lethal injection were, “I feel my whole body burning.”

Video: Larry Flynt vs. The Death Penalty

And compounding pharmacies—special labs that customize drugs for particular clients—have a far from spotless record in quality control. Their lack of regulation and risks came to light in the 2012 meningitis outbreak that spread from one of them.
Again and again, state correctional departments have found themselves stymied by the fact that the supply chains relied on to procure lethal-injection drugs are now international. In 2011, for instance, the U.S. pharmaceutical company Hospira (HSP)announced it would no longer produce Pentothal and pointed to the Italian government’s role in the decision. The company had been planning to produce the drug at a facility in Italy, but officials there made clear their strong disapproval of its use in capital punishment. “[W]e cannot take the risk that we will be held liable by the Italian authorities if the product is diverted for use in capital punishment,” Hospira said in its announcement, which noted that the company itself had never intended Pentothal to be used in executions.continue to read here

The New Yorker Witnesses to a Botched Execution April 30, 2014

Posted by Paige Williams

On Tuesday night, just after 8 P.M., a series of chilling tweets from an Associated Press reporter in Oklahoma City, Bailey Elise McBride, began to circulate widely. Before joining the AP, McBride was a high-school teacher. She writes a blog called PBR & Pearls, on which she logs inspirations and interests; most recently, a “mild obsession” with the band Tiny Ruins. At work, her subject matter tends to be darker. In addition to covering a mysterious case of dead birds dropping from the sky and the financial complications prompted by a bridge closure, McBride was one of the reporters following Oklahoma’s plans to execute two death-row inmates, on the same night, by lethal injection.
Both executions, of Clayton Lockett and Charles Warner, were to be carried out by midnight, and, as the Fordham law professor and death-penalty expert Deborah Denno told the Los Angeles Times, “The world was watching.”

Oklahoma had run out of lethal-injection drugs for the same reason that other death-penalty states have also run out of them. As Jeffrey Toobin described in a Talk of the Town piece, the sole American manufacturer of sodium thiopental, a key ingredient in lethal injections, stopped making the drug in 2011. Death-penalty states turned to European manufacturers, but it became impossible to import the drugs to the United States, owing to the European Union’s commitment to wipe out capital punishment worldwide. Left with dwindling supplies, states shifted their execution protocols toward the improvisational, recombining drugs and seeking the services of compounding pharmacies, which are loosely regulated by the federal government.
Where are states getting these chemicals? And how are they tinkering with them? These are excellent questions, but new secrecy laws allow certain states, Oklahoma among them, to remain completely silent on the matter. Constitutional challenges based on Eighth Amendment protections against cruel and unusual punishment have failed. Lethal injection—supposedly ethically superior to hanging, gas, electrocution, and firing squad—has been employed with untested and controversial drug combinations that are bought, with legally protected secrecy, from companies that want anonymity. Texas is refusing to reveal the source of its newest compounded drugs; Georgia considers the names of its suppliers a “state secret.” Secrecy laws involving lethal injection have been attacked, unsuccessfully, in Missouri and Louisiana.

continue to read here

Three More Laboratories Receive RMTC Accreditation April 30, 2014

Twenty-Three States Now Using RMTC-Accredited Laboratories

The Horseracing Testing Laboratory Committee of the Racing Medication and Testing Consortium (RMTC) has approved full accreditation of three laboratories under the RMTC Laboratory Accreditation Program. The newly accredited laboratories are:

Industrial Laboratories in Wheat Ridge, Colo.
Ohio Department of Agriculture laboratory in Columbus, Ohio, and
Truesdail Laboratories in Tustin, Calif.

RMTC-accredited laboratories are responsible for the testing of samples for 23 of the 34 racing jurisdictions in the United States, including AR, AZ, CA, CO, DE, ID, IN, KY, MA, MD, ME, MN, ND, NE, NJ, NM, NV, OH, OK, OR, VA, WA and WY. With the addition of these three laboratories there are now a total of five laboratories that are fully accredited by the RMTC – the UC Davis Kenneth L. Maddy Equine Analytical Chemistry Laboratory and the LGC Sports Science Laboratory were accredited in 2013.

“We applaud these laboratories for expending significant time and resources to achieve compliance with the RMTC Laboratory Accreditation standards for expertise and proficiency,” said RMTC Chair Alex Waldrop. “RMTC Accreditation is built upon protocols established by the World Anti-Doping Agency – the gold standard in human competition.”

“While the goal remains to have 100% of the laboratories that are testing horse racing samples RMTC-accredited, we are encouraged by having the majority of racing jurisdictions working with RMTC-accredited laboratories,” said Dr. Dionne Benson, executive director and COO of the RMTC.

Each laboratory receiving RMTC Accreditation has first been ISO 17025 certified, which is the international standard for analytical laboratories. Additionally, they must:

Submit an application which is reviewed by an independent auditor;
Successfully complete a multi-day laboratory site inspection with an internationally recognized expert in the field; and
Pass two rounds of the RMTC External Quality Assurance Program proficiency sample testing, which measures the ability of the laboratory to identify, detect and quantify (where appropriate) substances of concern in horse racing.

“We are gratified by the news of RMTC’s accreditation of our horseracing laboratory,” said Truesdail Laboratories Director Dr. Norm Hester. “We extend a formal "Thank You" to RMTC for recognizing us as compliant with their high standards for testing and allowing us to join the ranks of the relatively few organizations that share their approval. We are thrilled to be part of their goal of having 100% of racing laboratories accredited to their comprehensive requirements.”

“Industrial Laboratories is honored to have achieved RMTC Accreditation, and we thank our staff for their wonderful work,” said its director of drug testing services, Petra Hartmann. “Our laboratory looks forward to working with the RMTC and other industry partners for positive changes in the field of pari-mutuel drug testing – which will ultimately strengthen the integrity of the sport and protect the health and welfare of horses and jockeys.”

The RMTC consists of 23 racing industry stakeholders and organizations that represent Thoroughbred, Standardbred, American Quarter Horse and Arabian racing. The organization works to develop and promote uniform rules, policies and testing standards at the national level; coordinate research and educational programs that seek to ensure the integrity of racing and the health and welfare of racehorses and participants; and protect the interests of the racing public.

For additional information, visit the RMTC website at rmtcnet.com or contact Hallie Lewis, RMTC director of communications, at (859) 224-2848.

- See more at: http://www.ntra.com/en/news-media/press-releases/2014/4/30/three-more-laboratories-receive-rmtc-accreditation/#sthash.BqQpwy4l.dpuf

Horse Racing Groups Denounce Top Trainer Over Animal Mistreatment

By Ernie Smith / Apr 30, 2014
READ ARTICLE HERE

DeLauro Statement on Inspector General Report on Compounded Drugs

Issued By

Rosa L. DeLauro

April 30, 2014

Urges Centers for Medicare & Medicaid Services to Implement Recommendations WASHINGTON, DC-Congresswoman Rosa DeLauro (D-CT) released the following statement today on a new report from the Health and Human Services (HHS) Inspector General, Compounded Drugs Under Medicare Part B: Payment and Oversight. DeLauro is the senior Democrat on the subcommittee responsible for funding HHS and is the former chairwoman of the subcommittee responsible for funding the Food and Drug Administration (FDA), which has responsibility for overseeing compounded drugs.
"As the tragic outbreak of 2012-2013 demonstrated, our current system of tracking and ensuring the safety of compounded drugs is systemically flawed. The Inspector General's recommendations make clear that we need to do far more to track compounded drugs, particularly in the Medicare program as seniors are more susceptible to becoming seriously ill or dying from an infection than the general public. I am disturbed that we could be wasting millions of taxpayer dollars on unsafe drugs, with no way of knowing for sure. While I introduced legislation which would have made FDA registration mandatory for companies that mass produce compounded drugs, the bill signed into law unfortunately made that registration only voluntary. The current system still leaves our seniors and general population vulnerable and we need to change it. HHS should use the IG recommendations to take step to better protect our seniors from potentially dangerous compounded drugs."

The Inspector General issued three recommendations:
·         Establish a method to identify Medicare Part B claims for compounded drugs
·         Explore the possibility of requiring providers to identify the pharmacy that produced the compounded drug on the Medicare Part B claim
·         Explore the possibility of conducting descriptive analyses of Medicare Part B claims for compounded drugs. Such analyses could include calculating how much Medicare Part B is paying for compounded drugs, determining where compounded drugs are being produced and determining which compounded drugs are being billed for.

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